FDA.reportPublic FDA data

STATCUP®

Primary DI
00816036026613
Brand
STATCUP®
Company
MICRO DISTRIBUTING, L.C
Model
SCP-32107-0-A
Catalog number
SCP-32107-0-A
Device description
STATCUP SCP-32107-0-A,10 Panel Test Cup w/Adulterants, AMP/BAR/BUP/BZO/COC/mAMP/MTD/MOR/OXY/THC + CR,OX,pH, 25Pcs/Box
Published
2020-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DISEnzyme Immunoassay, Barbiturate
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
LAFGas Chromatography, Methamphetamine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LAFGas Chromatography, MethamphetamineClinical Toxicology2
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816036026613PrimaryGS10
00816036027115Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816036026613008160360266138160360266130816036026613
00816036027115008160360271158160360271150816036027115

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
866-933-0964info@micro-distributing.com

Regulatory Flags#

DUNS number
087732173
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816036026668STATCUP® SCP-31107-0SCP-31107-02021-01-14
00816036026569STATCUP® SCP-31107-0-ASCP-31107-0-A2019-07-02
00816036025432STATCUP® IISTAII-3187-0STATII-3187-02020-03-23
00816036025456STATCUP® IISTAII-03107-0-ASTAII-03107-0-A2021-08-03
00816036025470STATCUP® IISTATII-0247-0STATII-0247-02022-02-09
00816036025951STATDIP®DTH-40-0DTH-40-02020-06-02
00816036026590STATCUP® SCP-6157-0-ASCP-6157-0-A2020-03-17
00816036026606STATCUP® SCP-6167-0-ASCP-6167-0-A2020-03-17
00816036026620STATCUP® SCP-2277-0-ASCP-2277-0-A2020-09-09
00816036026637STATCUP® SCP-51127-0-ASCP-51127-0-A2020-09-28
00816036026644STATCUP® SCP-6157-0SCP-6157-02021-01-14
00816036026651STATCUP® SCP-2387-0-ASCP-2387-0-A2021-01-14
00816036026675STATCUP® SCP-21107-0-ASCP-21107-0-A2022-03-24
00816036027504STATSWAB3SS3-058SS3-0582021-09-16
00816036027511STATSWAB3SS3-158SS3-1582021-09-16
00816036027528STATSWAB3SS3-168SS3-1682021-09-16
00816036027535STATSWAB3SS3-048SS3-0482021-11-09
00816036027542STATSWAB3SS3-068SS3-0682021-11-09
00816036025487STATCUP® SCP-2397-0-ASCP-2397-0-A2023-07-25
00816036025340STATCUP® IISTATII-43147-0-ASTATII-43147-0-A2019-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LAF2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJR2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LAF2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJR2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.LDJ2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.JXM2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DIO2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DJG2017-11-15
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2016-09-23
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2016-09-23
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJR2016-09-23
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2016-09-23